Clinical trial · Interventional
HPV (Human Papilloma Virus) Vaccination After Treatment of Anal Intraepithelial Neoplasia (AIN)
Quadrivalent HPV Vaccination After Effective Treatment of Anal Intraepithelial Neoplasia in HIV+ Men
NCT02087384CI-TRIAL-00050484VACCAIN-PcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates vaccination with the quadrivalent HPV vaccine (Gardasil) versus placebo vaccination on prevention of high grade AIN recurrence in HIV-positive MSM (men who have sex with men) who were successfully treated for high grade AIN.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AIN | Anal Intraepithelial Neoplasia | ALIAS | 0.90 |
| HIV | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gardasil | Biological | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gardasil
- description
- Gardasil
- interventionNames
- Biological: Gardasil
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Intramuscular Saline 0.9% vaccination at 0, 2 and 6 months
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Cumulative recurrence of intra-anal or peri-anal HG AIN at 12 months after the last vaccination (18 months after inclusion), as assessed by HRA, with biopsies taken of suspect lesions.
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent. * Age ≥ 18 years. * HIV+ MSM, CD4 count \> 350/ul (maximum 6 months before screening visit). * Biopsy-proven intra-anal high-grade AIN successfully treated in the past year with cauterization, cryotherapy, Efudix, imiquimod or another form of local treatment. A maximum interval of 1 year between last treatment and first vaccination is allowed. Lesions with regression from HG to LG AIN (AIN 1) will also be eligible. * Lesions (still) in remission: * Remission has to be established by 2 independent HRA anoscopists. * A maximum interval of 3 months is allowed between the first of these HRAs and the first vaccination, and a maximum interval of 6 weeks is allowed between the second of these HRAs and the first vaccination. * Biopsies of suspect lesions need to be obtained in one of the HRA sessions. * Good performance status (a Karnofsky performance score of ≥ 60 \[on a scale of 0 to 100, with higher scores indicating better performance status\]). * Pre-treatment haematology, and plasma ASAT, ALAT and creatinine levels compatible with study inclusion (maximum 6 weeks before screening visit). Exclusion criteria: * Immunosuppressive medication or other diseases associated with immunodeficiency. * Life expectancy less than one year. * Previous HPV vaccination. * History of anal cancer. * Other diseases not compatible with study participation. * Allergy against constituent of Gardasil ® vaccine. * Currently peri-anal AIN2 or 3.
References
Publications (0)
Data not yet available
No reference posted for this study.